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“The extension of the transitional period and the removal of the “date of sell” provision in MDR.”

“The extension of the transitional period and the removal of the “date of sell” provision in MDR.”

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The goal of MDR/IVDR - The amendment to regulations (EU) 2023/607 for the revision of MDR and IVDR aims to ensure a high level of public health protection, including patient safety and the avoidance of medical device shortfalls necessary for the smooth running of medical services, without compromising the current quality or safety requirements. To this end, manufacturers and notified bodies have sufficient time to conduct conformity assessments of devices covered by certificates or declarations of conformity issued under directive 90/385/EEC or directive 93/42/EEC in accordance with the MDR. In addition, the "date of sale" is removed from the MDR and IVDR to prevent unnecessary disposal of safe equipment. In Article 120(4) of the MDR and Article 110(4) of the IVDR, the deadline for...
ISO 13485: Medical Devices Quality Management Standards

ISO 13485: Medical Devices Quality Management Standards

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What Is It? ISO 13485 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This international standard specifies the requirements for organisations that manufacture, design and/or distribute medical devices and related services. It provides a useful framework for medical devices’ quality management through its lifecycle and business processes. What Does It Do? By implementing this internationally recognised quality management system, you will enhance your business performance and demonstrate your compliance with best industry practices and quality control. The benefits of obtaining ISO 13485 certification can be further listed and not...
Quality Management System Services

Quality Management System Services

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We have highly experienced expertise to give you reliable consultancy and efficient service. Adopting a certified quality management system provides your organisation with a strong foundation of performance optimisation, brand transparency and continuous improvement. ISO 13485: Medical Devices Quality Management Standards FDA QSR: Compliance for Medical Device Manufacturers MDSAP: Medical Device Single Audit Program